Analytical Method Development: Qualification of Method Development Instruments – V 2.0
SOP for Qualification of Instruments Used in Analytical Method Development
| Department |
Analytical Method Development |
| SOP No. |
SOP/AMD/033/2025 |
| Supersedes |
SOP/AMD/033/2022 |
| Page No. |
Page 1 of 15 |
| Issue Date |
19/05/2025 |
| Effective Date |
20/05/2025 |
| Review Date |
19/05/2026 |
1. Purpose
This SOP defines the standardized procedure for the qualification of instruments used in analytical method development (AMD). It ensures instruments are appropriately installed, operated, and performing as intended before their use in method development or validation, in alignment with GMP and ICH Q10 standards.
2. Scope
This SOP applies to all new, relocated, or upgraded analytical instruments including HPLC, GC, UV-Vis spectrophotometers, dissolution apparatus, pH meters, and balances used in the AMD laboratory for method development and validation purposes.
3. Responsibilities
- Engineering/Service Team: Performs Installation Qualification (IQ) and assists with Operational Qualification (OQ).
- Analytical Scientist/Instrument Owner: Coordinates qualification activities, reviews vendor documents, and executes Performance Qualification (PQ).
- QA: Reviews all qualification documents and ensures release for GMP use.
- Head – AMD: Authorizes instrument use post-qualification and maintains instrument qualification status logs.
4. Accountability
The Head of AMD is accountable for ensuring no unqualified instrument is used for analytical method development or validation studies.
5. Procedure
5.1 Qualification Phases
- Each instrument must undergo the following:
- IQ – Installation Qualification
- OQ – Operational Qualification
- PQ – Performance Qualification
- Document each phase using Annexure-1: Instrument Qualification Checklist.
5.2 Installation Qualification (IQ)
- Ensure proper installation by service personnel as per manufacturer guidelines.
- Check for:
- Location conditions (power, humidity, temperature)
- Instrument part verification (serial numbers, cables, accessories)
- Software licenses and version control
- Record results in Annexure-2: IQ Report Template.
5.3 Operational Qualification (OQ)
- Verify functionality of all critical components, such as:
- Pumps, detectors, injectors (HPLC)
- Photometric accuracy (UV-Vis)
- Flow rate accuracy, column oven performance
- Perform OQ as per vendor protocols or internal templates.
- Record results in Annexure-3: OQ Report Template.
5.4 Performance Qualification (PQ)
- Run test samples, standards, and system suitability solutions to ensure reproducibility and accuracy.
- Conduct a minimum of three test runs using validated parameters.
- Ensure compliance with predefined criteria (RSD, retention time, absorbance, etc.).
- Document using Annexure-4: PQ Report Template.
5.5 Qualification Review and Approval
- Compile IQ, OQ, PQ documents into a qualification dossier.
- Submit for QA review and obtain approval using Annexure-5: Instrument Release for Use Form.
- Label qualified instruments with “Qualified” tag and maintain logbook entry with unique ID.
5.6 Requalification and Change Management
- Trigger requalification when:
- Instrument is relocated
- Major repair or component replacement
- Regulatory recommendation
- Partial or full requalification to be conducted based on impact assessment by QA.
- Log all requalification in the Instrument Master Qualification Register.
6. Abbreviations
- AMD: Analytical Method Development
- IQ: Installation Qualification
- OQ: Operational Qualification
- PQ: Performance Qualification
- QA: Quality Assurance
- HPLC: High Performance Liquid Chromatography
7. Documents
- Instrument Qualification Checklist – Annexure-1
- IQ Report Template – Annexure-2
- OQ Report Template – Annexure-3
- PQ Report Template – Annexure-4
- Instrument Release for Use Form – Annexure-5
8. References
- ICH Q10 – Pharmaceutical Quality System
- WHO TRS 937 – Equipment Qualification Guidelines
- US FDA 21 CFR Part 211 – Subpart D: Equipment
- GAMP 5 – Good Automated Manufacturing Practice
9. SOP Version
Version: 2.0
10. Approval Section
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Approved By |
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11. Annexures
Annexure-1: Instrument Qualification Checklist
| Instrument |
Type |
Make |
Model |
Required Qualification |
| HPLC-01 |
HPLC |
Waters |
2695 |
IQ, OQ, PQ |
Annexure-2: IQ Report Template
| Parameter |
Expected |
Observed |
Status |
| Electrical Supply |
220V |
220V |
Pass |
Annexure-3: OQ Report Template
| Component |
Test Performed |
Result |
Status |
| Pump Flow |
1.00 mL/min |
1.01 mL/min |
Pass |
Annexure-4: PQ Report Template
| Run No. |
Sample |
%RSD |
RT |
Status |
| 1 |
Standard |
0.8% |
5.83 |
Pass |
Annexure-5: Instrument Release for Use Form
| Instrument ID |
Approved By |
Date |
Remarks |
| HPLC-01 |
Sunita Reddy |
10/05/2025 |
Ready for AMD use |
Revision History:
| Revision Date |
Revision No. |
Details |
Reason |
Approved By |
| 04/05/2025 |
2.0 |
Updated PQ section and requalification triggers |
Regulatory audit recommendation |
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